NCT07496177

A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chronic Kidney Disease.

A Randomized, Double-blind, Placebo-controlled Mechanistic Study to Evaluate the Effect of HTD1801 in Delaying the Progression of Renal Impairment in Patients With Type 2 Diabetes and Chronic Kidney Disease.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD). Main Question it Aims to Answer: ▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo? Researchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline. Participants will: * Undergo screening tests to determine eligibility. * Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks. * Take the study medication twice daily for 12 weeks. * Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups. * Have their safety monitored through reporting of any health changes and routine lab tests.

Conditions

• T2DM
• CKD

Interventions

Type	Name	Description
DRUG	HTD1801	1000mg (as 4 capsules), twice a day for 12 weeks
OTHER	placebo	4 placebo capsules, twice a day for 12 weeks.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-31
• Completion: 2027-06-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China